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    Summary
    EudraCT Number:2007-002595-34
    Sponsor's Protocol Code Number:MRZ 92579-0707/1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-01-04
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2007-002595-34
    A.3Full title of the trial
    Efficacy and safety of neramexane mesylate in congenital idiopathic nystagmus and acquired nystagmus: a randomized, double-blind, placebo-controlled, single center, proof of concept study using a two-period cross-over design.
    A.4.1Sponsor's protocol code numberMRZ 92579-0707/1
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerz Pharmaceuticals GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNeramexane mesylate MR film-coated tablet 25 mg
    D.3.4Pharmaceutical form Modified-release tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeramexane Mesylate
    D.3.9.1CAS number 457068-92-7
    D.3.9.3Other descriptive name1-Amino-1,3,3,5,5-Pentamethylcyclohexane-Mesylate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboModified-release tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Congenital idiopathic nystagmus and acquired nystagmus
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029864
    E.1.2Term Nystagmus
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029867
    E.1.2Term Nystagmus congenital
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this cross-over study will be to investigate the safety and efficacy of neramexane mesylate at daily doses of up to 75 mg (target dose, reduction to 50 mg will be allowed) in the treatment of CIN in comparison to placebo. In addition, a subgroup of up to 20 MS patients (or fewer patients in case 28 patients with CIN have already been randomized) suffering from acquired nystagmus will be included and analyzed in an exploratory manner.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Only patients meeting all of the inclusion criteria and not presenting any of the exclusion criteria as listed will be considered for enrolment into the study.

    • patients with CIN or acquired nystagmus subsequent to MS;
    • male or female outpatients aged between 18 and 80 years (inclusive) at screening (visit 1);
    • patients with a nystagmus-related, best-corrected, reduced metric VA of 6/9 or worse (≤ 6/9);
    • for females of childbearing potential (last menses less than one year prior to enrolment): negative pregnancy test at screening and at baseline (i.e. prior to entry in the double-blind treatment phase); not breast-feeding; either surgically sterile or agreement to use a medically accepted, highly effective contraception during the entire duration of the study;
    • patients having given written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the patients’ routine care;
    • refraction done prior to enrolment, in particular in patients in whom the last refractive correction dates back to more than 12 months from screening. If required prescription and receipt of new glasses or contact lenses at least 2 weeks prior to the screening examination;
    • results of normal electrocardiogram (ECG) and safety laboratory at screening, or abnormal findings which are judged not clinically significant by the investigator;
    • absence of relevant medical disability or laboratory test results that, in the judgment of the investigator, would interfere with assessment of the tolerability, safety, or efficacy of the investigational compound or would compromise the patient's ability to provide informed consent;
    Congenital idiopathic nystagmus patients only:
    • normal results of electroretinography (ERG) and visually evoked potential (VEP) testing; historical results may be accepted if obtained according to International Society for Clinical Electrophysiology of Vision (ISCEV) standards within 3 years of the screening examination;
    • normal results of ophthalmological examination incl. slit lamp and funduscopy;

    Multiple sclerosis patients only:
    • diagnosis ‘multiple sclerosis’ as defined by 2005 Revisions to the McDonald criteria; neurologically stable with no evidence of acute relapse.
    • normal results of ophthalmological examination incl. slit lamp and funduscopy other than optic nerve atrophy;
    E.4Principal exclusion criteria
    Patients in whom any of the following criteria applies at the first study visit, i.e. screening visit (Visit 1, Period 1) of the cross-over trial will be excluded from the study enrolment.

    Patients presenting with uncontrolled arterial hypertension (SBP >160 mmHg and/or DBP >100 mmHg), arterial hypotension (SBP <90 mmHg and/or DBP <50 mmHg), and/or orthostatic dysregulation at the second baseline visit (Visit 5, Period 2) will be excluded from further trial participation.

    • diseases affecting the vestibular organ in the inner ear;
    • patients with evidence of neurologic disorders other than CIN such as congenital nystagmus due to albinism or retinal diseases and/or acquired nystagmus (exemption: secondary to MS), including, but not limited to epilepsy, infranuclear disorders such as benign paroxysmal positional vertigo (BBPV), vestibular neuritis, Menière’s disease, superior canal dehiscence syndrome, vestibular paroxysmia, or superior oblique myokymia;
    • nystagmus due to tumor lesions (e.g. pituitary tumors);
    • nystagmus due to inflammatory processes other than MS;
    • patients with known hypersensitivity or intolerance to neramexane, amantadine, or memantine; patients with intake of non-permitted concomitant medication;
    • prior exposure to gabapentin or memantine for the treatment of nystagmus (patients treated with these medications in the past for other reasons may be enrolled if last dose administered at least 1 month before screening visit);
    • simultaneous participation in another clinical trial or participation in any clinical research study evaluating another investigational compound within 3 months prior to screening;
    • patients with evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine, psychiatric or cardiovascular system disease (patients with medically controlled stable hypertension and/or diabetes may be enrolled);
    • patients with uncontrolled arterial hypertension (SBP >160 mmHg and/or DBP >100 mmHg), arterial hypotension (SBP <90 mmHg and/or DBP <50 mmHg), and/or orthostatic dysregulation;
    • patients with known active systemic bacterial, viral or fungal infections, or a known diagnosis of HIV or hepatitis C infection;
    • patients with an oncology diagnosis/malignancy (hematology or solid tumor) currently undergoing treatment, completion of such treatment within the past six months, or who still have evidence of active disease (except for successfully treated basal or squamous cell carcinoma of the skin);
    • known or suspected alcoholism or drug abuse;
    • unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition that is likely to affect the patient’s returning for scheduled follow-up visits on schedule;
    • employees or direct relatives of an employee of the CRO, the investigational site or medical students of the University of Leicester or Merz Pharmaceuticals; patients who are lawfully kept in an institution or are imprisoned
    • any other condition which in the opinion of the investigator would compromise patient safety or interfere with the interpretation of study results;
    Multiple sclerosis patients only:
    • history of epileptic seizures or a history of cardiac arrhythmias (as evidenced by ECG);
    • diagnosis of macular edema prior to randomization; patients presenting with acute optic neuritis.
    E.5 End points
    E.5.1Primary end point(s)
    The primary response variable in this trial will be the mean best corrected VA which will be measured prior to treatment initiation and at the end of each of the two treatment periods of the cross-over trial, i.e. after 7 weeks of treatment. The measurement will be performed at null point at distance (4m) using the LogMAR VA charts and with both eyes opened.

    Central VA is the clinically most relevant variable and represents the ‘gold standard’ by which the outcomes of drug therapy (or other interventions) are measured in this indication in the framework of clinical trials. In this study, LogMAR will be used as a primary response variable rather than the traditional Snellen notation.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-01-04. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-11-06
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